- Astellas Pharma (Northbrook, IL)
- …remote work are encouraged to apply. **Purpose and Scope:** We are seeking an experienced CMC Regulatory Affairs Director with deep expertise in the United ... Affairs, Quality Assurance, Business Partners). Responsible for developing regional/global CMC regulatory strategy (eg, CMC strategy/planning for… more
- BeOne Medicines (Emeryville, CA)
- …assigned projects. The individual will provide support to cross-functional teams on CMC regulatory strategies and process optimizations on relevant topics. ... the job:** + Lead, develop and implement small molecule CMC regulatory strategies as well as authoring...throughout product life cycle. Escalate the critical issues to senior management timely. + Lead or contribute to development… more
- Lilly (Indianapolis, IN)
- …are determined to make life better for people around the world. **Job Summary** The Director / Senior Director , CMC , Drug Product Development will lead ... capabilities in drug product development and manufacturing + Author CMC sections of regulatory submissions (IND, CTA) related to drug product development and… more
- UTMB Health (Huntsville, TX)
- Technical Supervisor, Lab Serv - CMC - Estelle **Huntsville, Texas, United States** Allied Health UTMB Health Requisition # 2505527 The mission of Correctional ... workflow for the division; and communicate with staff, management, and senior leadership. **_ESSENTIAL JOB FUNCTIONS_** **:** . Responsible for recruitment, hiring,… more
- Sumitomo Pharma (Lincoln, NE)
- …of the product + Supports the global regulatory lead (GRL) and the CMC regulatory lead in the formulation of regulatory strategy, and interactions ... a dynamic, highly motivated, and experienced individual for the position of **Associate Director , Regulatory Affairs (Oncology).** The Associate Director is… more
- Bristol Myers Squibb (Princeton, NJ)
- …at work and in their personal lives. Read more: careers.bms.com/working-with-us . **Sr Director , Global Regulatory Strategy, Neuroscience** + Will be a key ... Leadership Team to ensure the development, implementation, and alignment of regulatory strategies across projects and the Neuroscience therapeutic area. + Acts… more
- Lilly (Indianapolis, IN)
- …to make life better for people around the world. **Purpose:** The purpose of the Senior Director Global Regulatory Affairs, Global Regulatory Lead (GRL) ... experience for 10 years + Direct experience in clinical and CMC regulatory sciences + Experience in applicable therapeutic area neuroscience and/or immunology… more
- ThermoFisher Scientific (Greenville, NC)
- …all while maintaining full-time benefits. **Position Summary** The Director , Clinical Regulatory Affairs serves as a senior regulatory leader responsible ... RFIs to support timely trial startup and advancement. The Director , Clinical Regulatory Affairs partners closely with...programs, territories, and development milestones. + Serve as the senior regulatory advisor to program teams, helping… more
- Amgen (Washington, DC)
- …10 million patients worldwide. It's time for a career you can be proud of. Regulatory Policy and Intelligence - US Director **Live** **What you will do** Let's ... stakeholders (eg, Global Government Affairs, R&D, Commercial, Legal) with a strategic regulatory policy perspective + Assists and advises senior leadership in… more
- Takeda Pharmaceuticals (Boston, MA)
- …roles, with deep expertise across Pharmaceutical Sciences + Strong understanding of CMC processes, GxP, regulatory compliance and global quality standards + ... & Technology (DDT) portfolio driving innovation and operational excellence across the CMC lifecycle. This leadership role is accountable for shaping and delivering… more
- Otsuka America Pharmaceutical Inc. (Waltham, MA)
- **Job Summary** The Senior Director will serve as the Translational Medicine CNS Therapeutic Area Head, reporting to the VP, Translational Medicine and Early ... Clinical Development within OPDC's Early Development Organization (EDO). The Senior Director Translational Medicine will oversee a small team of CNS… more
- Gilead Sciences, Inc. (Foster City, CA)
- …than 35 countries worldwide, with headquarters in Foster City, California. ** Senior Director ,** **Product Management** **Team** **Lead** **(Early Phase)** ... operating within the broader Pharmaceutical Development and Manufacturing (PDM) organization, the ** Senior Director , Product Management Team Lead** will lead a… more
- Gilead Sciences, Inc. (Foster City, CA)
- …their aspirations. Join Gilead and help create possible, together. **Job Description** ** Senior Director , Global Supplier Quality** Gilead Sciences, Inc. is a ... External Quality is currently seeking a leader at the Senior Director level to lead a team...Technical Development, Packaging Development and Engineering, Global Manufacturing, Procurement, Regulatory CMC , and the Gilead Site Quality… more
- Teva Pharmaceuticals (Parsippany, NJ)
- Senior Director , Site Quality Head, Goa...technology transfer, cGMPs, EU, ICH guidelines as well as CMC content of regulatory submissions, + Deep ... and Laboratory Operations to ensure a mature culture of quality, compliance with regulatory requirements and quality of products. This oversight includes but is not… more
- Takeda Pharmaceuticals (Boston, MA)
- …company that will inspire you and empower you to shine? Join us as a Senior Director , Global Program Leader - Oncology, Solid Tumors in our Cambridge office. ... experienced, versatile and strong enterprise leaders + Committed to simultaneously driving regulatory approval as well as launch and global patient access + Ability… more
- Capgemini (New York, NY)
- …(no sponsorship). **Preferred** + Former **FDA/CDER/CBER** reviewer experience. + VP/ Director Regulatory experience in **first-time submissions** (IND → ... €22.5 billion. **Job:** **Organization:** _INVENT PEOPLE S&T_ **Title:** _Capgemini Invent - Senior / Managing Consultant - Life Sciences, Regulatory Affairs &… more
- Alloy Therapeutics (Waltham, MA)
- …with external partners to discover and develop AntiClastic RNA medicines. The Role The Director to Executive Director of Nucleic Acid Chemistry will lead a team ... from research scale to GMP production, ensuring robustness, reproducibility, and regulatory compliance. + Implement Quality by Design (QbD) principles to establish… more
- Lilly (Indianapolis, IN)
- …and diverse portfolio of ADCs, we are seeking a highly experienced and strategic Senior Director to lead our payload linker development efforts within the ... + Experience working with ADC projects, especially regarding the unique CMC and regulatory considerations, is a plus. + Strong leadership skills with a… more
- M&T Bank (Buffalo, NY)
- …including interest rate risk, market risk, and liquidity risk. + Represent IRM on senior committees ( CMC , Executive ALCO, MRC) and provide updates to Governance ... solutions. The position ensures alignment with both economic and regulatory requirements, while driving strategic risk governance and cross-functional… more
- AbbVie (Irvine, CA)
- …required by program needs, in partnership with Discovery, Translational, and CMC colleagues contribute to design and implement translational strategies. May ... strong medical and scientific principles, knowledge of compliance and regulatory requirements, AbbVie's customers, markets, business operations and emerging issues.… more
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